Senior Biostatistician – Oncology (FSP -Permanent Homebased) job opportunity at IQVIA Holdings, Inc..

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IQVIA Holdings, Inc. Senior Biostatistician – Oncology (FSP -Permanent Homebased)
Experience: 5-years
Pattern: full-time
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degreePhD
loacation Reading, Berkshire, United Kingdom, United Kingdom
loacation Reading, Berks..........United Kingdom

We are seeking an experienced and proactive   Senior Biostatistician   to join our FSP team, supporting a global pharmaceutical client. This is a   permanent, home-based   position offering the opportunity to work on   late-phase global oncology trials , with a focus on   hematology   and   regulatory submissions . Key Responsibilities Serve as the   lead statistician   on global   late-phase registration trials , particularly in oncology (hematology preferred). Independently contribute to   study design ,   statistical analysis plans (SAPs) , and   regulatory submission strategies . Participate in   study team meetings , providing statistical guidance and collaborating with cross-functional teams. Address   health authority questions   and support responses with appropriate statistical analyses and documentation. Perform   hands-on statistical programming   to derive outputs and summary statistics using   ADaM   and   SDTM   datasets. Ensure timely and accurate delivery of statistical deliverables in compliance with regulatory standards Required Qualifications Advanced degree (Master’s or PhD) in   Biostatistics ,   Statistics , or a related field. 5+ years   of experience in clinical trials, with a strong focus on   oncology   (hematology and late-phase preferred). Proven experience working on   registrational studies   and   regulatory submissions . Strong knowledge of   CDISC standards , particularly   ADaM   and   SDTM . Proficiency in   SAS   programming and ability to perform hands-on statistical analyses. Excellent communication skills and ability to work independently in a global, cross-functional environment. Preferred Experience Prior involvement in   FDA/EMA submissions . Experience addressing   regulatory agency queries . Familiarity with   real-world evidence   and   observational studies   is a plus. Why Join Us? Work on   high-impact global studies   with a focus on improving cancer treatment outcomes. Be part of a   collaborative and innovative   team environment. Enjoy the   flexibility of remote work   with a permanent contract. Gain exposure to   regulatory strategy   and   cutting-edge oncology research . IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

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